The U.S. Food and Drug Administration (FDA) has granted SELZENTRY™ (maraviroc) full (traditional) approval for use in treatment-experienced adults with CCR5-tropic HIV-1 in combination with other antiretrovirals. SELZENTRY was originally granted accelerated conditional approval in August 2007 based on 24-week data from pivotal Phase 3 studies. SELZENTRY now becomes the latest fully approved treatment for HIV.
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AstraZeneca Settles US Pulmicort Respules Patent Litigation with Teva
AstraZeneca has entered into a settlement agreement in its Pulmicort Respules patent infringement litigation against Ivax Pharmaceuticals, Inc., a wholly owned subsidiary of Teva Pharmaceuticals USA. The agreement settles the patent infringement litigation filed by AstraZeneca following Teva's submission to the United States Food & Drug Administration of an Abbreviated New Drug Application for a generic version of Pulmicort Respules.
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Sandoz receives positive EU opinion for biosimilar filgrastim
Sandoz has received a positive opinion from European regulators for its third biosimilar medicine, filgrastim, marking another important milestone in its efforts to bring affordable high-quality biopharmaceuticals to patients worldwide.
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Johnson & Johnson Announces Definitive Agreement to Acquire Omrix
Johnson & Johnson (NYSE: JNJ) and Omrix Biopharmaceuticals, Inc. (NASDAQ: OMRI), a fully integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, have announced a definitive agreement whereby Omrix will be acquired for approximately $438 million in a cash tender offer.
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GSK and Neptunus form joint venture for the co-development of flu vaccines
GlaxoSmithKline (GSK) has signed an exclusive Cooperation Agreement with Shenzhen Neptunus Interlong Bio-Technique Co. Ltd. (NIBT) as a preliminary step in forming a Joint Venture (JV) between the two companies. The agreement outlines the proposed terms for establishing a JV company, which will seek to co-develop seasonal influenza vaccines and pre-pandemic/pandemic influenza vaccines, firstly targeting against strains of the virus specific to China, Hong Kong and Macau.
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AstraZeneca to divest Nordic over-the-counter portfolio
AstraZeneca has announced the divestment to GlaxoSmithKline of a portfolio of over-the-counter (OTC) products predominantly sold in Sweden. The decision reinforces AstraZeneca's strategy to focus on innovation in prescription medicines.
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Pfizer withdraws its application to change the marketing authorisation for Viagra
The European Medicines Agency (EMEA) has been formally notified by Pfizer Limited of its decision to withdraw its application for a change to the marketing authorisation for the medicine Viagra (sildenafil) 50 mg film-coated tablets.
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